MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK HIP FEMORAL STEM

Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Scarring (2061); Tissue Damage (2104); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number is not available.

Event Description

Patient was revised to address pain.Intraoperative finding of corrosion and black residue on the trunnion and inside the head.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot codes were not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Rec'd 05/02/2016 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from elevated metal ion levels and limited mobility.Complaint updated 05/18/2016.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot codes were not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges metal wear/ metallosis confirmed by medical records.After review of medical record of mdr reportability, patient was revised to address pain.Revision notes reported of significant scarring, there was a small amount of corrosion within the inside of femoral head as well as on the trunnion.Clinical notes reported of osteolysis, poly wear and elevation of metal ions.There is no lab results for metal ions.Updated lot number of head and liner.

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provision depuy synthes of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5494703
• MDR Text Key: 40139300
• Report Number: 1818910-2016-15085
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK083642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 06/25/2018; 06/25/2018; 11/26/2019
• Supplement Dates FDA Received: 04/20/2016; 05/18/2016; 07/08/2016; 06/26/2018; 07/19/2018; 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 106